Can Vessel Preparation Minimize Residual Stenosis and Improve - - PowerPoint PPT Presentation

Can Vessel Preparation Minimize Residual Stenosis and Improve Outcomes?

Professor Thomas Zeller Department of Angiology University Heart Center Freiburg-Bad Krozingen Bad Krozingen, Germany

Purpose of Vessel Preparation

Creates an optimal environment for angioplasty:

FLEX Vessel Preparation System

Sheath Size 6 French Wire Compatibility .014 and .018 Catheter Length 40cm and 120cm 3 Atherotomes (Proximal) 0.01” in Height CE Mark / FDA Indication for Use: To facilitate dilation of stenoses in the femoral and popliteal arteries and treatment of

• bstructive lesions of native or synthetic

arteriovenous dialysis fistulae

The FLEX System

• 3 Proximal Atherotomes Mounted on

Skids

• Controlled Depth Micro-Incision
• Retrograde Pull-Back
• Rotation Control (1:1 torque)
• A One Size Fits All Device.

OCT Image of Micro-Incision Histology of Micro-Incision (Cadaveric Human SFA)

Mechanism of Action

• Precise longitudinal micro-incisions
• Skid surface area prevents perforation
• Atherotomes interact with vessel surface at 1 atm
• Creates a controlled environment for angioplasty
• Basket “flexes” to plaque contour.

Parallel FLEX Micro-Incisions

Human cadaver SFA, SEM Image magnified 150x

Acute Real-World Data

• 457 Patients treated
• 66 Institutions, 100 Physicians

Definitions: Procedural Success: Residual Stenosis ≤ 30% Opening Balloon Pressure: Lowest pressure required to fully efface the lesion.

• Average Age: 71 years old
• Average Lesion Length: 13.7 cm
• Chronic Total Occlusions: 44%
• Average Baseline Stenosis: 92%

Vessel Preparation by the FLEX

• Angiogram is Captured Prior to

Angioplasty Evaluating Luminal Gain and Safety of the FLEX. Post FLEX Alone: Average Luminal Gain: 29.5%

Pre-Procedure Post FLEX

Procedural Results

• DCB utilized in 73% of cases
• Average Opening Balloon Pressure: 4.5 atm
• No Bail-Out Stenting Required
• Provisional Stent Use: 21.7%
• Average Residual Stenosis: 10%
• Procedural Success: 97.2%

Grade A Dissections 4.6% Grade B Dissections 1.3% Flow-Limiting Dissection 0% Perforation 0% Embolization 0%

Post FLEX & DCB

Stent Cohort

• No Flow-Limiting Dissections
• All Provisional
• Increased Average Lesion Length (cm)
• Higher percentage of CTOs
• No Change to FLEX Luminal Gain or Residual Stenosis

92 29.5 10 95 29.5 10

10 20 30 40 50 60 70 80 90 100

Baseline Stenosis Post FLEX Lumen Gain Residual Stenosis

All Cases Stent Cohort 2 4 6 8 10 12 14 16 18

All Cases Stent Cohort

13.7 16.6

10 20 30 40 50 60

Stent Cohort All Cases

60 44

Percentage of CTOs

Conclusion

• Vessel preparation with the FLEX System achieved a

high rate of procedural success. ¾ cases used DCB post FLEX.

• Low opening balloon pressures suggest improvement

in vessel wall compliance with use of the FLEX. Low dissection rate with no flow-limiting dissections.

• All stenting was provisional; longer lesions and CTOs

tended towards stenting.

• Further studies are warranted on the long-term

benefits.